Regulatory Affairs Associate

Location
San Diego, CA, United States
Posted
Sep 25, 2020
Ref
380VM
Hotbed
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
Fate Therapeutics is seeking an experienced and highly motivated regulatory professional to support the regulatory affairs team. The successful candidate must thrive in a fast-paced team environment and have excellent communication, planning, and organizational skills, with the ability to prioritize and have good time management skills under tight deadlines. The ideal candidate must be proficient in regulatory agency submission requirements, interpret guidance documents to support the development of strategy, drive life-cycle submissions, and be familiar with the use of electronic document management systems and quality management systems. This is a full-time position reporting to a Manager, Regulatory Affairs, and is located at our corporate headquarters in
San Diego, CA. Major

Responsibilities
Include:
• Coordinate the preparation, submission, and maintenance of domestic and international
regulatory submissions including INDs, CTAs, DMFs, amendments, safety reports, DSURs, annual
reports, information requests, and background materials for regulatory authority meetings
• Review documents required as part of the Regulatory Greenlight for the shipment of drug
product to the clinical sites
• Review regulatory submissions to ensure quality
• Research and evaluate regulations, guidances, and draft guidances to help support the
development of regulatory strategy
• Support RA filing goals through collaboration with Researchers, Development personnel and
Clinical Development personnel to ensure accuracy of regulatory submission content
• Create and maintain Regulatory Affairs schedules for domestic and international regulatory
filings to ensure alignment with agreed strategies
• Collaborate with other quality system stakeholders to develop SOPs and other quality system
documents to achieve compliance goals
• Support development of department policies, procedures and best practices commensurate
with the requirements of rapidly growing company
• Work in close partnership with Regulatory Operations to ensure accuracy and timeliness of
regulatory submissions
• Maintain knowledge of current regulatory environment and interpret and communicate
relevant issues
• Perform other duties as required

Requirements
• Bachelor's degree plus a minimum of 2 years' experience in RA, preferably in a clinical stage pharmaceutical or biotechnology company
• Experience performing electronic review of published submissions
• Knowledge of global regulatory health authority requirements for submissions
• Experience driving life-cycle submissions
• Understanding of regulatory and quality compliance requirements
• Strong organizational, analytical, and problem-solving skills
• Proficiency using Microsoft Word, Excel, Project, Adobe Acrobat Professional
• Experience using an EDMS system, particularly Veeva Regulatory Information Management
(RIM) Suite
• Strong team orientation, with excellent written and oral communication skills

Working Conditions and Physical Requirements
• May require occasional evening and weekend work
• Full-time onsite work at Company's headquarters in San Diego
• May require occasional travel for training programs and meetings The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.
For consideration send cover letter and resume to: careers@fatetherapeutics.com and reference job 380VM.

About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Company's immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Company's immuno-regulatory product candidates
include ProTmune™, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.